Compounding Pharmacy. Cleaning Consumables for. Products to meet USP<797> Requirements

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Cleaning Consumables for Compounding Pharmacy

Sterile Wipers Wipers Disinfectants Cleanroom Mops

Engineering Control C Counters F Floors W Walls Cl

1 Cleaning Consumables for Compounding Pharmacy Products to meet USP<797> Requirements Sterile IPA Sterile Wipers Wipers Disinfectants Cleanroom Mops Adhesive Mats LEGEND 5 ISO Class 5 Primary Engineering Control C Counters F Floors W Walls Cl Ceilings S Storage Shelving USP <797> Requirements Page 1

Table of Contents Cleaning Areas Chart Pg. 1 Sterile IPA Pg. 2 Disinfectants Pg.

5 About Texwipe Texwipe s commitment to innovation, leadership and quality in cleanroom

We invest in technology to respond to our customer s evolving needs in contamination

Our Core Values are: Innovation - Texwipe pioneers the latest technologies to provide

Quality - Texwipe product quality is maintained by the most advanced testing and quality

Technology Leadership - Texwipe leads our industry in testing metrology, methods and

Throughout Texwipe s global operations, we support our customers with products designed to

Our highly professional team will help you select and develop products for any critical

9 1 2 3 4 Supplies removed from shipping cartons are wiped with sterile 70% isopropyl

2 Table of Contents Cleaning Areas Chart Pg. 1 Sterile IPA Pg. 2 Disinfectants Pg. 3 Sterile Wipers Pg. 4 Wipers Pg. 5 About Texwipe Texwipe s commitment to innovation, leadership and quality in cleanroom consumable products spans more than fifty years. We invest in technology to respond to our customer s evolving needs in contamination control. Our Core Values are: Innovation - Texwipe pioneers the latest technologies to provide innovation in contamination control products and processes. Quality - Texwipe product quality is maintained by the most advanced testing and quality control standards in the industry. Technology Leadership - Texwipe leads our industry in testing metrology, methods and processes to reduce contamination. Throughout Texwipe s global operations, we support our customers with products designed to exceed the requirements for cleanroom consumable products. Our highly professional team will help you select and develop products for any critical environment application. USP <797> Requirements Mops Pg. 6 Mats Pg. 8 INDEX Pg Supplies removed from shipping cartons are wiped with sterile 70% isopropyl alcohol. Floors, walls, ceilings and shelving are cleaned with sterile 70% isopropyl alcohol or a disinfecting agent. Hard surfaces must be cleaned and then wiped with sterile 70% isopropyl alcohol or a residue-free disinfecting agent prior to compounding. Contaminated gloved hands may be disinfected by wiping or rubbing sterile 70% isopropyl alcohol to all contact surface areas of the gloves. LEGEND 5 ISO Class 5 Primary Engineering Control C Counters F Floors W Walls Cl Ceilings S Storage Shelving

3 Cleaning and Disinfecting Compounding Areas Site ISO Class 5 Primary Engineering Control (e.g., LAFW, BSC, CAI, CACI) 5 Counters and easily cleanable work surfaces C Floors F Walls W Ceilings Cl Storage Shelving S Recommended Texwipe Products Minimum Frequency At the beginning of each shift, before each batch, not longer than 30 minutes following the previous surface disinfection when ongoing compounding activities are occurring, after spills, and when surface contamination is known or suspected Daily Daily Monthly Monthly Monthly Disinfectants Sterile IPA Cleaners Sterile Pre-Wetted Wipers Sterile Dry Wipers Mops and Covers Wipers Pre-Wetted Wipers Mats 3 The United States Pharmacopeial Convention. USP<797> Pharmaceutical Compounding - Sterile Preparations. Pg. 28, Table 3. USP <797> Requirements Page 1

SOLUTIONS Sterile IPA Sterile Isopropyl Alcohol (IPA) 5 C F W Cl S Sterile 70% Isopropanol contains 70% by volume USP-grade Isopropanol (isopropyl alcohol) and 30% USP-purified water.

The solution is submicron filtered, filled into cleaned containers, double-bagged and gammairradiated. Each bottle is lot coded with an expiration date for easy recordkeeping.

4 SOLUTIONS Sterile IPA Sterile Isopropyl Alcohol (IPA) 5 C F W Cl S Sterile 70% Isopropanol contains 70% by volume USP-grade Isopropanol (isopropyl alcohol) and 30% USP-purified water. This is a fully assembled, ready-to-use applicator/container; no unpacking, handling or attachment of a separate spray head is required. The solution is submicron filtered, filled into cleaned containers, double-bagged and gammairradiated. Each bottle is lot coded with an expiration date for easy recordkeeping. Trigger Spray Customers can choose a stream delivery (for precise application) or course spray to apply solution to larger areas. available in 4 convenient sizes. Bulk Container Gallon size available. Sterile IPA Trigger spray, 8 fluid ounces (237 ml) 12 polybottles/case Trigger spray, 16 fluid ounces (473 ml) 12 polybottles/case Trigger spray, 32 fluid ounces (946 ml) 12 polybottles/case Bulk container, 1 gallon (3.8 liters) 4 polybottles/case LEGEND 5 ISO Class 5 Primary Engineering Control C Counters F Floors W Walls Cl Ceilings S Storage Shelving Page 2 Sterile IPA Solution

SOLUTIONS TexQ Disinfectant 5 C F W Cl S Now Gamma Irradiated! The all-in-one disinfectant.

in ready-to-use or concentrate. TexQ Disinfectant is an EPA-registered (10324-85) quaternary ammonium compound (quat) which serves as an effective one-step cleaner/disinfectant.

TexQ Disinfectant is available in two solutions: Ready-to-Use trigger spray (TX650) and Concentrate gallon bottle (TX651).

Quaternary Ammonium Compound 19034970 TexQ Disinfectant Ready-to-Use (RTU) 22 oz.

cleaning solutions are developed for use within cleaning rotation cycles to maintain a clean environment and reduce Volatile Organic Carbon (VOC) concerns.

5 SOLUTIONS TexQ Disinfectant 5 C F W Cl S Now Gamma Irradiated! The all-in-one disinfectant. TexQ Disinfectant This solution is the only disinfectant your cleanroom needs it s highly effective against a wide spectrum, a one-step disinfectant & cleaner, fragrance free, dye free, and available in ready-to-use or concentrate. TexQ Disinfectant is an EPA-registered ( ) quaternary ammonium compound (quat) which serves as an effective one-step cleaner/disinfectant. It is effective against a broad spectrum of bacteria, virus and fungi, and inhibits the growth of mold and mildew and their odors when used as directed. TexQ Disinfectant is available in two solutions: Ready-to-Use trigger spray (TX650) and Concentrate gallon bottle (TX651). Both solutions contain the same active ingredients and final concentrations, requiring only a single qualification for TX650 and TX651, and are 0.2 μm filtered. Quaternary Ammonium Compound TexQ Disinfectant Ready-to-Use (RTU) 22 oz. trigger spray, 12 bottles/case TexQ Disinfectant Concentrate 1 gallon concentrate, 4 bottles/case TexP Hydrogen Peroxide 5 C F W Cl S TexP Hydrogen Peroxide Texwipe s Hydrogen Peroxide cleaning solutions are developed for use within cleaning rotation cycles to maintain a clean environment and reduce Volatile Organic Carbon (VOC) concerns. Convenient ready-to-use solutions offer a low toxicity profile, requiring no mixing or activation. TexP does not leave a residue and may be used for disinfectant residue removal. Safe, non-corrosive formula (on most common surfaces) and completely biodegradable. Solutions are available in two RTU concentrations 4% and 7.5% and both are available in a handy 16 oz spray bottle for small areas and 1 gallon bottles for large areas. Individually lot coded for ease of traceability and quality control. Labeled in three languages (English, Spanish, French). Hydrogen Peroxide % hydrogen peroxide RTU solution 16 oz. spray bottle % hydrogen peroxide RTU solution 1 gallon bottle % hydrogen peroxide RTU solution 16 oz. spray bottle % hydrogen peroxide RTU solution 1 gallon bottle TexQ Disinfectant Page 3

Synthetic wipers are made of 100% continuous-filament cleanroom-laundered polyester. Blended wipers are hydroentangled blends of polyester and cellulose.

6 STERILE WIPES Sterile Dry Wipes 5 C S Texwipe invented and patented the sealed-border wiper to prevent the release of particles and fibers. These wipers have set the standard as the cleanest, most effective wipers for ISO Class 3-5 cleanrooms and mini environments. Synthetic wipers are made of 100% continuous-filament cleanroom-laundered polyester. Blended wipers are hydroentangled blends of polyester and cellulose. Sterile Wipers 18335B SterileWipe HS II / 12" x 12" nominal (31 cm x 31 cm) 100 wipers/bag, 5 inner bags of 20 wipers, 5 bags/case 18335C SterileWipe HS II / 9" x 9" (23 cm x 23 cm) 100 wipers/bag, 10 packs of 10 wipers, 5 bags/case SterileWipe AS 10 / 12" x 12" nominal (31 cm x 31 cm) 100 wipers/bag, 5 packs of 20 wipers, 5 bags/case Sterile Pre-Wetted Wipes 5 C S Sterile pre-wetted wipers are packaged in resealable flatpacks and flexpacks. They offer a convenient alternative to wipers and alcohol spray bottles. Benefits include: Optimizes solution usage for effective particulate removal Eliminates overspray of alcohol Eliminates the handling, preparation, documentation and validation of in-house production of pre-wetted wipers Reduces IPA spill potential and eliminates the storage and disposal of excess solvents Minimizes VOCs (volatile organic compounds) Sterile Pre-Wetted Wipers Sterile TechniSat / 9" x 11" (23 cm x 28 cm) 50 wipers/flexpack, 24 flexpacks/case Sterile TechniSat / 9" x 11" (23 cm x 28 cm) 20 wipers/flexpack, 24 flexpacks/case Sterile PolySat / 9" x 11" (23 cm x 28 cm) 20 wipers/flexpack, 24 flexpacks/case Sterile AlphaSat 10 / 9" x 9" (23 cm x 23 cm) 20 wipers/flexpack, 20 flexpacks/case LEGEND 5 ISO Class 5 Primary Engineering Control C Counters F Floors W Walls Cl Ceilings S Storage Shelving Page 4 Sterile Wipers

See the USP<797> Minimum Frequency Chart for use recommendations regarding dry and pre-wetted wipers.

7 WIPES Dry Wipes 5 C S Texwipe has cleanroom wipers that meet all USP<797> requirements. Ranging in substrates from synthetic to polyester/cellulose blends, we offer wipes in both dry and pre-wetted forms. See the USP<797> Minimum Frequency Chart for use recommendations regarding dry and pre-wetted wipers. Wipers 18315C TechniCloth / 9" x 9" (23 cm x 23 cm) 300 wipers/bag, double-bagged, 10 bags/case VersaWipe / 9" x 9" (23 cm x 23 cm) 300 wipers/bag, double-bagged, 10 bags/case AlphaWipe / 9" x 9" (23 cm x 23 cm) 150 wipers/bag, 2 inner bags of 75 wipers; 10 bags/case ThermaSeal / 9" x 9" (23 cm x 23 cm) 150 wipers/bag, 2 inner bags of 75 wipers; 10 bags/case Pre-Wetted Wipes 5 C F W Cl S Texwipe has cleanroom wipers that meet all USP<797> requirements. Ranging in substrates from synthetic to polyester/cellulose blends, we offer wipes in both dry and pre-wetted forms. See the USP<797> Minimum Frequency Chart for use recommendations regarding dry and prewetted wipers. Pre-Wetted Wipers A TechniSat / 6" x 8" (15cm x 20cm) pre-wetted with 70% IPA TechniSat / 9" x 11" (22.9cm x 27.9cm) pre-wetted with 70% IPA 100 wipers/canister, 12 canisters/case 50 wipers/flexpack, 24 flexpacks/case Wipers Page 5

MOPS AlphaMop 5 F W Cl S The Big Clean. Designed for easy cover changes, this large flat mop is ideal for cleaning surfaces such as ceilings, floors and walls.

Texwipe AlphaMop features a large 15" x 8" (38 cm x 20 cm) thermoplastic mop head, 60" (1.5 m) fiberglass handle, pad and fastening pins.

8 MOPS AlphaMop 5 F W Cl S The Big Clean. Designed for easy cover changes, this large flat mop is ideal for cleaning surfaces such as ceilings, floors and walls. The padded head allows for a consistent contact with different surfaces. The covers easily fit over the head permitting a quick change. Texwipe AlphaMop features a large 15" x 8" (38 cm x 20 cm) thermoplastic mop head, 60" (1.5 m) fiberglass handle, pad and fastening pins. Quick-change system allows the user to replace covers / pads frequently, adhering to strict cleaning protocols. The polyester pad assures the mop cover to conform to surfaces for consistent cleaning. Low profile, swivel head with lightweight handles enables easier cleaning of floors, walls, ceilings and hard-toreach areas. Available in standard and autoclave safe models. AlphaMop Fisher Scientific Cat. No. Name / Description Packaging Mop Hardware AlphaMop / 15" x 8" Cleanroom mop with handle and single head assembly 1 mop/case Autoclavable AlphaMop / 15" x 8" thermoplastic single head assembly 60" fiberglass handle 1 mop/case Mop Covers AlphaSat Pre-Wetted Mop Covers 8" x 15" (20 cm x 38 cm) pre-wetted with 6% IPA AlphaMop Mop Covers 8" x 15" (20 cm x 38 cm) Polyester mop covers and foam pads Sterile AlphaMop Covers polyester replacement covers and pads Replacement Parts AlphaMop Foam Pad Replacement Kit Foam pads and clips for use with AlphaMop TX7108 and TX7108A 25 mop covers/bag, 4 bags/case = 100 mop covers 4 foam pads/case 150 mop covers/case, (6 bags of 25 mop covers) 6 foam pads/case 125 covers and 25 pads/case (12 bags of 10 covers and 1 pad) 25 foam pads and 4 clips/bag 3 bags/case LEGEND 5 ISO Class 5 Primary Engineering Control C Counters F Floors W Walls Cl Ceilings S Storage Shelving Page 6 Mops

MOPS Isolator Cleaning Tool 5 F W Cl S Specially engineered to work with isolators and other small areas, this easy-to-maneuver tool offers lightweight, one-hand operation.

Engineered for quick cover changes during operation, the padded head allows for a consistent mop across different surfaces without losing cleaning power.

9 MOPS Isolator Cleaning Tool 5 F W Cl S Specially engineered to work with isolators and other small areas, this easy-to-maneuver tool offers lightweight, one-hand operation. Its low-profile, swivel head allows the Isolator Cleaning Tool to get into hard-to-reach places. Engineered for quick cover changes during operation, the padded head allows for a consistent mop across different surfaces without losing cleaning power. The rounded edges clean the isolator corners and prevent scratches or damages to surfaces. The low-profile, swivel head Texwipe s Isolator Cleaning Tool/Mini AlphaMop Systems feature a 7" x 4" (18 cm x 10 cm) thermoplastic mop head, pads and fasteners. Choose from your choice of handle options: TX7101 offers 2 handles at 12" (30.4 cm) and 18" (45 cm) fixed lengths each, and TX7104 offers a telescoping handle reaching from 29" - 53" (73 cm cm). Autoclave safe. Mini AlphaMop Fisher Scientific Cat. No. Name / Description Packaging Mop Hardware Isolator Cleaning Tool with Mini AlphaMop / 3.7" x 7.1" (9.4 cm x 18.1 cm) Mini cleanroom mop with 2 extension handles plus foam pad and starter pack of covers Mini AlphaMop / 3.7" x 7.1" (9.4 cm x 18.1 cm) Mini cleanroom mop with 1 telescoping handle plus foam pad and starter pack of covers Mop Covers Sterile Mini AlphaMop Covers polyester replacement covers and pads Mini AlphaMop Replacement Covers Microdenier polyester mop covers 1 mop/case, 2 handles (12" and 18") 1 foam pad, 6 covers (TX7114) 1 mop/case, 1 telescoping handle (telescopes from 2 5" to 4 5") 1 foam pad, 6 covers (TX7114) 120 covers and 12 pads/case (25 bags of 5 covers and 1 pad) 150 mop covers/case (6 bags of 25 mop covers) 6 foam pads/case Mops Page 7

Whether cleaning protocols require portability or the surface just isn t conducive to adhesives, CleanStep s mix of sizes and colors are sure to fit the bill. 36 mat/frame combinations.

10 MATS Mats F Time-Saving, Floor-Saving The CleanStep Adhesive Mat removes traffic-borne particulates prior to entering the clean work area. It features an antimicrobial additive in an environmentally friendly adhesive. Whether cleaning protocols require portability or the surface just isn t conducive to adhesives, CleanStep s mix of sizes and colors are sure to fit the bill. 36 mat/frame combinations. Adhesive Mats Mats White base, clear film / 18" x 36" / 30 layers 8 mats per case Blue base, clear film / 25" x 45" / 30 layers 8 mats per case Gray base, clear film / 36" x 46" / 30 layers 8 mats per case Frames Frame: 19" x 37" (for mat size 18" x 36") Color: Black 1 frame per case Frame: 26" x 46" (for mat size 25" x 45") Color: Black 1 frame per case Frame: 37" x 47" (for mat size 36" x 46") Color: Black 1 frame per case LEGEND 5 ISO Class 5 Primary Engineering Control C Counters F Floors W Walls Cl Ceilings S Storage Shelving Page 8 Mats

11 INDEX Fisher Scientific Cat. No. Desciption Page 18315C TechniCloth / 9" x 9" (23 cm x 23 cm) AlphaWipe / 9" x 9" (23 cm x 23 cm) B SterileWipe HS II / 12" x 12" nominal (31 cm x 31 cm) C SterileWipe HS II / 9" x 9" (23 cm x 23 cm) SterileWipe AS 10 / 12" x 12" nominal (31 cm x 31 cm) TechniSat / 9" x 11" (22.9 cm x 27.9 cm) pre-wetted with 70% IPA " x 37" (for mat size 18" x 36") Color: Black " x 46" (for mat size 25" x 45") Color: Black " x 47" (for mat size 36" x 46") Color: Black Sterile IPA Trigger spray, 32 fluid ounces (946 ml) AlphaMop Foam Pad Replacement Kit Foam pads and clips Sterile TechniSat / 9" x 11" (23 cm x 28 cm) A TechniSat / 6" x 8" (15cm x 20cm) pre-wetted with 70% IPA AlphaMop / 15" x 8" Cleanroom mop with handle and single head assembly Autoclavable AlphaMop / 15" x 8" thermoplastic single head assembly 60" fiberglass handle Sterile TechniSat / 9" x 11" (23 cm x 28 cm) Ready-to-Use (RTU) Concentrate % hydrogen peroxide RTU solution 16 oz spray bottle % hydrogen peroxide RTU solution 1 gallon bottle % hydrogen peroxide RTU solution 16 oz spray bottle % hydrogen peroxide RTU solution 1 gallon bottle AlphaMop Mop Covers 8" x 15" (20 cm x 38 cm) Polyester mop covers and foam pads Sterile PolySat / 9" x 11" (23 cm x 28 cm) Mini AlphaMop / 3.7" x 7.1" (9.4 cm x 18.1 cm) Mini AlphaMop Replacement Covers Microdenier polyester mop covers Sterile Mini AlphaMop Covers polyester replacement covers and pads Sterile AlphaMop Covers polyester replacement covers and pads Trigger spray, 8 fluid ounces (237 ml) Sterile AlphaSat 10 / 9" x 9" (23 cm x 23 cm) White base, clear film / 18" x 36" / 30 layers Blue base, clear film / 25" x 45" / 30 layers Gray base, clear film / 36" x 46" / 30 layers VersaWipe / 9" x 9" (23 cm x 23 cm) ThermaSeal / 9" x 9" (23 cm x 23 cm) Bulk container, 1 gallon (3.8 liters) Trigger spray, 16 fluid ounces (473 ml) AlphaSat Pre-Wetted Mop Covers 8" x 15" (20 cm x 38 cm) pre-wetted with 6% IPA Isolator Cleaning Tool with Mini AlphaMop / 3.7" x 7.1" (9.4 cm x 18.1 cm) 7 INDEX Page 9

12 BN

PRODUCT NO.:

PRODUCT NO.: 7182-01 STARTER KIT (Germfree) For GermFree Glove Box DESCRIPTION: This convenient starter kit will allow the operator to jumpstart their cleaning with the GermFree Compounding Aseptic Isolator